STARCLOSE VASCULAR CLOSURE SYSTEM
FDA premarket approval P050007 · decided 2005-12-21
Approval details
- PMA number
- P050007
- Trade name
- STARCLOSE VASCULAR CLOSURE SYSTEM
- Generic name
- Device, hemostasis, vascular
- Applicant
- Abbott Vascular Devices
- Date received
- 2005-02-28
- Decision date
- 2005-12-21
- Days to decision
- 296 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL FOR THE STARCLOSE VASCULAR CLOSURE SYSTEM. THE DEVICE IS INDICATED FOR THE PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS, AMBULATION, AND DISCHARGEABILITY IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ENDOVASCULAR CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM (K052454) | Abbott Vascular Devices | 2005-09-14 |
| MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM (K050501) | Abbott Vascular Devices | 2005-03-14 |